TRABAJO REGULATORY QA

·         apply strategic regulatory thinking along with technical expertise to implement regulatory strategies for product...

The  associate director – regulatory submissions is responsible to lead a worldwide regulatory submissions delivery team within iqvia translations...

Ability to interpret global regulatory standards... presents information logically and concisely, both verbally and in writing, including writing reports with clarity...

Provide qa support for technology transfer and improvement of existing manufacturing processes... responsible for product release, ensuring products meet cgmp, janssen...

Calibration rationales, calibration master forms and completed calibration records, master data set-up, maintenance plans and follow up daily operations activities...

Work closely with regulatory to develop effective regulatory and cmc strategies... experience leading projects in the qa department... experience in qa and ra departments...

\u extensive knowledge of pharmaceutical research and development processes and regulatory environments... \u evaluate policies and procedures for compliance with...

Experience and skills: required: excellent understanding and application of global regulatory (cgmp/ich/fda/ema) guidelines... for this project we want to strengthen...

Participate in the qa annual program of self-inspections... collaborate in audits carried out by our clients or subcontracted manufacturers and give support in the...

Conocimientos específicos: gmps / regulatory affairs en eu, fda, mercado no regulado... desde mabxience, compañía especializada en el desarrollo y fabricación de...

Calling all senior qa managers, this is a unique opportunity to make real change within the medical device field... 8 years within quality preferably in the medical...

Experience: • practical experience of at least 3 years in the pharmaceutical industry, a majority of which has been gained in a qa environment... •  control of narcotics/controlled...

Issue, review and approve documents and sign the certificates of analysis of batches manufactured for release or for regulatory purposes on different countries to...

Global responsibilityassure compliance of gmp, regulatory and internal standards according to quality policies and applicable requirements within the organization...

Promotes standardization of auditing approach within qa... contributes to the qa strategy and supports qa goals for the aligned studies\/countries in a given ta\/region...

O   experience hosting global regulatory agency inspections and successfully presenting product and quality compliance programs to regulatory reviewers...

Participating in the selection of the qa team members... the role is responsible to support and facilitate the regulatory affairs activities to ensure that products...

Experience interfacing with global regulatory agencies... perform qa approvals of quality event records... keep up to date with latest guidelines from mhra, fda...